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MedDRA stands for Medical Dictionary of Regulatory Affairs |
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Standard dictionary for Adverse Events and mandated for use in SAE reporting by the US FDA and EMEA |
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Maintained by Northrop Grumman, formerly TRW, via an awarded contract by an internal consortium of regulatory agencies and pharmaceutical companies. |
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The MSSO division of Northrop Grumman maintains the MedDRA dictionary and sells subscriptions |
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Updated every 6 months, with releases ending in .0 for March releases and .1 for Sep releases |
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MedDRA primarily contains 5 levels
SOC
System Organ Class, this is the most general level of classifying an AE
HLGT
High Level Group Term
HLT
High Level Term
PT
Preferred Term
LLT
Lowest Level Term (This is usually the term coded against). |
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SMQs, or Standard MedDRA Queries, as of release 9.0 which allow “broad” and “narrow” conditionally based grouping of terms (mostly PTs) by special general disease/indication categories. |
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| © 2008 Mithas Labs. All rights reserved. |
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